1. Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement
- Author
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Nicolas Dumonteil, Géraud Souteyrand, Jacques Monségu, Mohamed Abdellaoui, Patrick Staat, Easy Tavi Investigators, Isabelle Durand-Zaleski, Benjamin Faurie, Eric Van Belle, Thierry Lefèvre, Matthieu Godin, Pierre Meyer, Christophe Caussin, and Lionel Mangin
- Subjects
Male ,medicine.medical_specialty ,Cardiac Catheterization ,Pacemaker, Artificial ,Time Factors ,Transcatheter aortic ,medicine.medical_treatment ,Cost-Benefit Analysis ,Operative Time ,030204 cardiovascular system & hematology ,Radiation Dosage ,Cardiac Catheters ,Ventricular Function, Left ,Rapid pacing ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,0302 clinical medicine ,Valve replacement ,Cost Savings ,Risk Factors ,Internal medicine ,Medicine ,Humans ,Single-Blind Method ,030212 general & internal medicine ,Prospective Studies ,Hospital Costs ,Aged ,Aged, 80 and over ,business.industry ,Cardiac Pacing, Artificial ,Radiation Exposure ,Treatment Outcome ,Aortic Valve ,Heart Valve Prosthesis ,Cardiology ,Ventricular Function, Right ,Procedure Duration ,Female ,France ,Cardiology and Cardiovascular Medicine ,business - Abstract
This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation.Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR).This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days.Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001).Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).
- Published
- 2019